The NIH Director

Statement on FDA’s Proposed Oversight of Laboratory-Developed Tests

July 31, 2014

I applaud today’s announcement by the Food and Drug Administration (FDA) that it plans to take steps to improve the oversight of laboratory-developed tests (LDTs). This is good news for all who are working to turn the dream of personalized medicine into a reality.

The FDA has long required premarket review of commercial test kits sold to laboratories, hospitals, clinics, or directly to the public as home test kits. In addition to commercial tests, many laboratories have been developing, using, and marketing their own LDTs for decades. FDA has historically used its enforcement discretion to allow certain LDTs, such as those for rare genetic disorders or those performed within a hospital for care of local patients, to be developed and used without formal FDA approval or clearance.

In pre-draft guidance unveiled today, the FDA has proposed a risk-based, phased-in plan aimed at leveling the playing field for all test manufacturers, as well as ensuring the safety and efficacy of LDTs. NIH supports our sister agency’s proposal and thinks that this thoughtful framework — which focuses greatest attention on tests with the most significant clinical impact — will protect public health, without putting a damper on biomedical innovation or placing an undue burden on industry.